Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
160 participants
INTERVENTIONAL
2025-07-07
2026-09-30
Brief Summary
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GERD is a chronic condition that affects quality of life, and patients with this condition are known to have a lower quality of life compared to healthy individuals. In particular, nocturnal heartburn can lead to sleep deprivation and affect daily life, as well as overall quality of life.
This study aims to evaluate the efficacy of alleviating nocturnal heartburn symptoms in patients with erosive reflux disease (ERD).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Zastaprazan
Zastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks
Zastaprazan
Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.
Esomeprazole
Esomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks
Esomeprazole
Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.
Interventions
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Zastaprazan
Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.
Esomeprazole
Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD)
3. Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1)
4. Those who voluntarily decided to participate and provide written informed consent
Exclusion Criteria
2. Individuals with a history of drug or alcohol abuse (within the past year)
3. Individuals who have received other investigational products within one month prior to the screening visit (Visit 1)
4. In addition to the above, individuals with clinically significant findings that the investigator deems medically inappropriate for the present study
19 Years
ALL
No
Sponsors
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Incheon St.Mary's Hospital
OTHER
Responsible Party
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Byung-Wook Kim
Professor
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Chilgok, , South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Soonchunhyang University Hospital
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Byung-Wook Kim
Role: primary
Other Identifiers
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JL-JAQ-402
Identifier Type: -
Identifier Source: org_study_id